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Slightly-alkaline sodium acetate ringer's injection and preparation method

A technology of Ringer's injection and sodium acetate, applied in pharmaceutical formulations, anhydride/acid/halide active ingredients, medical preparations containing active ingredients, etc., can solve the problems of unstable pH, slow pH drop, etc. Influence and avoid the effect of acid-base imbalance

Inactive Publication Date: 2016-06-29
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After the implementation of the above patents, it was found that when the pH of the injection was adjusted to be basically the same as that of the blood, affected by the hydrolysis of carbon dioxide during the preparation process, sterilization and storage, the pH would slowly drop, causing the pH to be unstable and unable to be consistent with the blood pH

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] (1) Fill the preparation tank with decarbonated air so that the air in the preparation tank is completely replaced;

[0030] (2) Add 2000L carbon dioxide-free water for injection into the preparation tank;

[0031] (3) Weigh and add 19.95kg of sodium chloride, 0.945kg of potassium chloride, 0.63kg of calcium chloride, and 12.635kg of sodium acetate, stir to dissolve, and dilute to 3500L with carbon dioxide-free water for injection;

[0032] (4) Adjust the pH of the liquid to 7.48 with hydrochloric acid;

[0033] (5) Filter the liquid medicine through a 0.2 micron folded filter element;

[0034] (6) Continuously fill the glass infusion bottle with decarbonated air protection, and fill and seal it under decarbonated air protection;

[0035] (7) Autoclave at 121°C for 12 minutes in a water-bath sterilizer to get ready.

Embodiment 2

[0037] (1) Fill the preparation tank with nitrogen to completely replace the air in the preparation tank;

[0038] (2) Add 3000L carbon dioxide-free water for injection into the preparation tank;

[0039] (3) Weigh and add 22.05kg of sodium chloride, 1.155kg of potassium chloride, 0.77kg of calcium chloride, and 13.965kg of sodium acetate, stir to dissolve, and dilute to 3500L with carbon dioxide-free water for injection;

[0040] (4) Adjust the pH of the medicinal solution to 7.30 with acetic acid;

[0041] (5) Filter the liquid medicine through a 0.2 micron folded filter element;

[0042] (6) Continuously fill the semipermeable infusion bag with nitrogen protection, and fill and seal it under nitrogen protection. The semipermeable infusion bag is covered with a high-barrier bag and filled with nitrogen to seal;

[0043] (7) Autoclave at 121°C for 15 minutes in a water-bath sterilizer to get ready.

Embodiment 3

[0045] (1) Fill the preparation tank with inert gas so that the air in the preparation tank is completely replaced;

[0046] (2) Add 2500L carbon dioxide-free water for injection into the preparation tank;

[0047] (3) Weigh and add 21kg of sodium chloride, 1.05kg of potassium chloride, 0.7kg of calcium chloride, and 13.3kg of sodium acetate, stir to dissolve, and dilute to 3500L with carbon dioxide-free water for injection;

[0048] (4) Adjust the pH of the medicinal solution to 7.41 with acetic acid;

[0049] (5) Filter the liquid medicine through a 0.2 micron folded filter element;

[0050] (6) Continuously fill the semipermeable infusion bag with inert gas protection, and fill it under the protection of inert gas. The semipermeable infusion bag is covered with a high barrier bag and filled with inert gas to seal;

[0051] (7) Autoclave at 121°C for 15 minutes in a water-bath sterilizer to get ready.

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PUM

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Abstract

The invention discloses a slightly-alkaline sodium acetate ringer's injection. Every 1,000 ml of the injection contains 5.7-6.3 g of sodium chloride, 0.27-0.33 g of potassium chloride, 0.18-0.22 g of calcium chloride and 3.61-3.99 g of sodium acetate. The preparation method of the injection comprises steps as follows: a preparation tank is filled with neutral gas for protection, then carbon-dioxide-free water for injection is added, all components are sequentially put into the water to be dissolved, and the volume is metered; the pH of the medicine liquid is adjusted to range from 7.3 to 7.5 and the medicine liquid is filtered; a packaging container is continuously filled with neutral gas for protection, potting is performed under the protection of the neutral gas, the semi-transparent packaging container is sleeved with a high-barrier bag, and vacuum pumping or neutral gas filling is performed for sealing; the injection is obtained after sterilization. The injection is stable in pH and can better play functions of regulating acid-base balance of organisms and supplementing electrolytes.

Description

technical field [0001] The invention belongs to the field of medicine and chemical industry, and relates to a weakly alkaline sodium acetate Ringer injection and a preparation method thereof. Background technique [0002] Extracellular fluid is a relatively stable internal environment required for the normal metabolism of cells in the body. In many disease processes, the balance of body fluids is often disrupted, resulting in abnormal water, electrolyte and acid-base balance and corresponding clinical manifestations, even life-threatening. Reasonable, safe, and simple water and electrolyte supplementation and acid-base imbalance correction are the most basic treatments. [0003] At present, physiological saline or compound sodium chloride injection is commonly used in clinic to supplement extracellular fluid and correct water and electrolyte balance, but its acid-base balance ability is relatively weak. Adding sodium lactate on the basis of compound sodium chloride injecti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/14A61K9/08A61P3/12A61K31/19
CPCA61K33/14A61K9/0019A61K9/08A61K31/19A61K2300/00
Inventor 任传杰魏倩倩王杰
Owner SHANDONG QIDU PHARMA
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